DRW Medical NAPA LP-15 User manual

NAPA™LP-15
AIRWAY PRESSURE MONITOR
User’s Manual

Copyright © DRW Medical, LLC
All rights reserved.
DRW Medical, LLC
2710 Concord Road
Aston, PA 19014
Phone: [phone]
www.drwmedical.com

NAPA LP-15 AIRWAY PRESSURE
MONITOR USER MANUAL
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NAPA LP-15 Airway Pressure Monitor User’s Manual
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Table of Contents
Table of Contents........................................................................3
1. General Information...........................................................7
1.1 About This Manual.....................................................7
1.2 Manufacturer Information .........................................7
1.3 Classification ..............................................................7
2. Safety Information .............................................................8
2.1 Safety Warnings .........................................................8
2.2 Safety Notes............................................................. 11
3. Intended Use ....................................................................12
3.1 Indications for Use ................................................... 12
3.2 Contraindications..................................................... 12
3.3 Essential Performance..............................................13
4. Introduction –Functional Description .............................. 13
4.1 Principles of Operation............................................. 13
5. Controls, Displays, and Indicators..................................... 16
5.1 NAPA LP-15 Airway Pressure Monitor Front Panel ... 16
5.2 NAPA LP-15 Airway Pressure Monitor Side Panel.....19
5.3 NAPA LP-15 Airway Pressure Monitor Rear Panel .... 19
5.4 Symbols Used on the Monitor.................................. 20
5.5 Symbols Used on the Monitor Label and Packaging . 21

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6. Setup and Operation.........................................................23
6.1 Connecting the NAPA LP-15 Airway Pressure Monitor
to AC Mains Power................................................................23
6.2 Attaching LP-15 to Pole Mount.................................24
6.3 Normal Operation of the NAPA LP-15 Airway Pressure
Monitor (FIGURE 8) ...............................................................26
6.4 Connecting the NAPA LP-15 Airway Pressure Monitor
to the Patient Circuit (FIGURE 9) ...........................................27
6.5 Full BCPAP System with NAPA LP-15 Airway Pressure
Monitor Schematic................................................................30
7. Alarms and Alarm Limits ...................................................31
7.1 NAPA LP-15 Airway Pressure Monitor Alarms
Overview...............................................................................31
7.2 Alarm Condition Types .............................................32
7.3 Alarm Delay..............................................................32
7.4 Alarm Limits .............................................................33
7.5 When an Alarm is Active: Operator Actions:.............33
7.6 Adjusting Alarm Settings (FIGURE 12).......................34
7.7 Alarm Suspend .........................................................35
7.8 Alarm Settings and Power Interruption ....................35
7.9 Alarm Verification.....................................................35
8. Performance Check...........................................................36

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8.1 Zeroing the Pressure Sensor (All Users)....................36
8.2 Functional Test (All Users) (FIGURE 13) ....................38
8.3 Monitor Pressure Accuracy Check (Biomedical
Engineer User) (FIGURE 14)................................................... 40
9. Maintenance ....................................................................42
9.1 Cleaning the NAPA LP-15 Airway Pressure Monitor.42
9.2 Troubleshooting.......................................................44
9.3 Gain Calibration (Performed only by Manufacturer) 45
9.4 NAPA Airway Pressure Monitor DC Power Supply.. 456
10. Catalog Item Numbers: NAPA LP-15 Airway Pressure
Monitor Parts & Accessories List...............................................47
11. Product Specifications .................................................. 48
12. Customer Service and Product Support ........................50
13. Electromagnetic Compatibility ..................................... 51
13.1 EMC Overview..........................................................51
13.2 EMC Declaration.......................................................53

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1. General Information
1.1 About This Manual
This user’s manual has been prepared to provide information
on the correct operation of the NAPA LP-15 Airway Pressure
Monitor. It contains performance specifications, installation,
operation and maintenance information.
This manual is intended for trained health-care
professionals. The NAPA LP-15 Airway Pressure
Monitor may only be used by clinically trained
operators with sufficient knowledge, training and
understanding of this user’s manual. The device
must only be used for the purposes described.
1.2 Manufacturer Information
Manufacturer: DRW Medical, LLC
Address: 811 Lincoln Dr., Brookhaven, PA 19015 USA
Telephone: [phone]
Website: www.drwmedical.com
1.3 Classification
This equipment is classified as protection Class II, type BF in
accordance with IEC 60601-1.

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2. Safety Information
2.1 Safety Warnings
Warnings are identified by the WARNING
symbol shown to the left.
Warnings alert you to potential serious
outcomes (death, injury, or adverse events) to the patient or
user, or system damage, if the relevant safety measures are
not observed.
General
•The NAPA LP-15 Airway Pressure Monitor is intended
for use by clinicians with training using airway
pressure monitoring devices.
•The NAPA LP-15 Airway Pressure Monitor is not a life
monitor and an attendant is needed at all times to
monitor the patient.
•Do not adjust alarm threshold parameters so widely
as to render the alarms useless.
•Only use the NAPA LP-15 Airway Pressure Monitor
with its intended patient population and application
–use on other patient types or modes of respiratory
support is not defined and may have unpredictable
functions.
•The NAPA LP-15 Airway Pressure Monitor is not
designed to measure patient respiratory cycles nor
to provide alarms for high or low pressure excursions

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related to the respiratory cycle. The device measures
and displays a two-second mean (average) airway
pressure for the specified intended application,
neonatal bubble CPAP. The device high and low
alarm thresholds respond to that two second mean
and not to changes within the respiratory cycle.
•The NAPA LP-15 Airway Pressure Monitor does not
display peak or real time airway pressures, and is not
intended to be used with a ventilator.
Safety and EMC
•Do not use oil or grease on the NAPA LP-15 Airway
Pressure Monitor for any reason.
•Do not use the NAPA LP-15 Airway Pressure Monitor
near open flames.
•The internal gas path in the NAPA LP-15 Airway
Pressure Monitor has been tested against leaks to
provide protection during use with enriched Oxygen
CPAP treatment –follow appropriate precautions
whenever sources of enriched Oxygen are used.
•Do not attempt to dismantle or to remove
components since tampering with the NAPA LP-15
Airway Pressure Monitor may cause the unit to
malfunction and will automatically void the
warranty.
•Do not use in the presence of flammable anesthetics
as this may constitute a fire or explosion hazard.
•To avoid personal injury or equipment damage, keep
the power supply cable out of the way of users.

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•Use the NAPA LP-15 Airway Pressure Monitor only
with its original power supply (Catalog Number
51002).
•The use of portable and mobile radio frequency (RF)
communications equipment can affect this and other
pieces of medical equipment.
•The use of accessories, power sources and cables
other than those specified by DRW Medical may
result in inaccurate readings of the device and
increased emissions or decreased electromagnetic
immunity of the device.
•The NAPA LP-15 Airway Pressure Monitor should not
be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary,
the equipment should be observed to verify normal
operation in the configuration in which it will be
used.
•Always ensure that the NAPA LP-15 Airway Pressure
Monitor, its pole mount, and the IV pole are secured
near the patient to prevent unwanted movement of
the system.
•The NAPA LP-15 Airway Pressure Monitor should
always be used on its pole mount –improper or
insecure mounting of the device can allow unwanted
movement of the monitor.
•Caution: In order to minimize problems with
condensation or moisture, the monitored patient
connection point should be at least 25 cm (10 in.)
lower than the unit.
•Do not connect the NAPA LP-15 Airway Pressure
Monitor to a source of airway pressure other than
CPAP pressure –excessive pressure can damage the
unit’s pressure sensor.

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Accessories
•Only the accessory parts specified for the NAPA LP-
15 Airway Pressure Monitor may be used with the
device. The use of incompatible components can
result in measurement error, degraded
performance, or injury.
•Reuse of accessories specified for single patient use
could pose an infection risk.
2.2 Safety Notes
NOTES are identified by the NOTE symbol shown
to the left.
NOTES provide important information about the product or
a specific part of the manual which should be read with
particular attention:
•Position the tubing at the patient to minimize the
possibility the tubing may be pulled on or interfere
with the patient’s position.
•Always ZERO the pressure sensor before use with the
pressure sensor open to room air.
•NOTE: Be aware there is a two-minute delay prior to
alarm activation following power-up.
•NOTE: The NAPA LP-15 Airway Pressure Monitor has
been designed for stationary hospital use only.
•NOTE: No high priority alarm conditions are provided
by the monitor because the NAPA LP-15 Airway

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Pressure Monitor measures pressure treatment
levels which are considered medium priority, not
patient vital signs such as breath rate, which are
considered high priority.
3. Intended Use
3.1 Indications for Use
The NAPA™LP-15 Airway Pressure Monitor is intended to
measure and monitor mean airway pressure for neonatal
patients being treated with positive pressure therapy,
including neonatal Continuous Positive Airway Pressure
(CPAP) devices (e.g. Bubble CPAP).
The device provides audible and visual alarms when the
airway pressure falls outside of the user selected high and
low alarm limits. The device is intended to be pole mounted
for stationary use in hospitals only. For professional use only.
CAUTION: Federal law (U.S.) restricts the sale of this
device to, or by the order of, a physician.
3.2 Contraindications
The NAPA™ LP-15 Airway Pressure Monitor is
contraindicated when the patient’s airway pressures are
above 35 cm H2O.

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3.3 Essential Performance
Essential Performance is performance with the absence or
degradation of which, would result in an unacceptable risk,
and includes the following functionalities:
•Indication of measured pressure value on display.
•Operation within specified measurement accuracy
limits ± 2.5 cm H2O or generation of either a technical
alarm condition or an indication of abnormal
operation.
•Generation of low and high alarm conditions or
generation of a technical alarm condition.
•No unintended change of operating mode.
•Recovery from any disruption within 30 seconds
without operator intervention
4. Introduction –Functional
Description
4.1 Principles of Operation
The NAPA LP-15 Airway Pressure Monitor is a
microprocessor-controlled, alarm and monitoring device
that measures, monitors, and continuously displays a two-
second mean airway pressure from 0-35.0 cm H2O during
Neonatal Continuous Positive Airway Pressure therapy (e.g.
Bubble CPAP) or as an independent backup pressure monitor
for devices without pressure measurement capability. The
NAPA LP-15 Airway Pressure Monitor alarms when the mean

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airway pressure falls outside of the user-selected high and
low pressure alarm limits, and displays mean airway
pressures.
The NAPA LP-15 Airway Pressure Monitor also includes an
alarm silence feature.
NOTE: The NAPA LP-15 Airway Pressure Monitor has
been designed for pole-mounted hospital use only.
FIGURE 1

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Overview of NAPA LP-15 Airway Pressure Monitor Features
•Software measures, monitors, and continuously
displays a two-second mean airway pressure from 0-
35.0 cm H2O
•Measures pressures from atmosphere as 0.0.
•Manual zero pressure sensor function.
•Intuitive user interface provides adjustable audio
and visual high and low airway pressure alarms
which allow bracketing the desired threshold to
within 0.1 cm; device alarms when the mean airway
pressure falls outside of the user-selected high and
low alarm limits.
•High Pressure Alarm: Provides a Medium Priority
audible and visual alarm when device detects mean
airway pressure 0.1 cm H2O above preset high limit
for 2 seconds and the yellow LED up arrow blinks.
The high alarm settings are from 6.0 to 35.0 cm H20.
•Low Pressure Alarm: Provides a Medium Priority
audible and visual alarm when the device detects
mean airway pressure 0.1 cm H2O below preset low
limits for 2 seconds. The yellow LED down arrow
blinks when there is a low pressure alarm event. Low
alarm settings are from 0.1 to 28.0 cm H20.
•Alarm Suspend button allows alarm to be silenced
for two minutes.
•Alarm resets after two minutes, or automatically
when the condition causing the alarm is corrected.

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5. Controls, Displays, and
Indicators
5.1 NAPA LP-15 Airway Pressure Monitor Front Panel
FIGURE 2

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The NAPA LP-15 Airway Pressure Monitor Front Panel
(FIGURE 2) includes the following elements:
SOFT KEYS:
•ON/OFF POWER BUTTON
•MENU-ENTER
oAllows you to scroll through the three
primary settings:
▪Low Alarm (L)
▪High Alarm (H)
▪Alarm Volume (A)
oAlso saves each setting prior to advancing to
the next setting
•TOGGLE UP Δ
oScroll up to adjust values of selected setting.
•TOGGLE DOWN ∇
oScroll down to adjust values of selected
setting.
•ALARM SUSPEND
oSilences the audible portion of the alarm for
2 minutes following the ALARM
SUSPEND Soft Key Press
•Zero Pressure Sensor Key →0 

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oA one second press and hold of this key
initiates the Zero Pressure Sensor –the
display flashes “0.0” when this operation is
successfully completed.
•Always ZERO the pressure sensor before use
with the pressure sensor open to room air.
LIGHTS/INDICATORS:
•ΔHIGH PRESSURE ALARM INDICATOR: Flashes when
high pressure limit is exceeded
•∇LOW PRESSURE ALARM SIGNAL: Flashes when low
pressure limit is exceeded

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5.2 NAPA LP-15 Airway Pressure Monitor Side Panel
The NAPA LP-15 Airway Pressure Monitor Side Panel (FIGURE
3) includes the following elements:
•LED Light
for power
status
•DC Power
Connector
5.3 NAPA LP-15 Airway Pressure Monitor Rear Panel
The NAPA LP-15 Airway Pressure Monitor Rear Panel
includes the following elements, pictured in Section 6.2,
FIGURE 5:
•Rear Label Location
•Mounting Screws for Pole Mount Bracket

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5.4 Symbols Used on the Monitor
The following symbols are used on the monitor:
Symbol
Description
On/Off Power Button
Menu Enter Control Key
Adjust Up Control Key (adjust value up)
Adjust Down Control Key (adjust value
down)
Alarm Suspend Control Key
→0 
Zero Pressure Sensor Key
LED Indicator: High Pressure Alarm
LED Indicator: Low Pressure Alarm
5.5 Symbols Used on the Monitor Label and Packaging
The following symbols are used on the monitor label: